Status:
TERMINATED
Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer
Lead Sponsor:
Sesen Bio, Inc.
Conditions:
Carcinoma, Squamous Cell of Head and Neck
Carcinoma, Squamous Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer.
Detailed Description
Head and neck cancer is a general description of a disease that includes several types of soft tissue carcinomas that develop in the head and neck regions. Proxinium is a recombinant fusion protein t...
Eligibility Criteria
Inclusion
- Disease Characteristics
- The patient must be 18 years of age or older.
- The patient must have squamous cell carcinoma of the head and neck.
- The squamous cell carcinoma must be Ep-CAM positive.
- ECOG performance status of 0, 1, 2 or 3.
- 12 week life expectancy
- Prior/Concurrent Therapy
- The patient must have received therapy for their primary disease (eg, surgery and/or radiotherapy, chemo-radiotherapy or chemotherapy).
- The patient must have been diagnosed with persistent or recurrent disease or a second primary tumour.
- The patient's disease must be refractory.
- There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy and receiving study drug or 4 weeks between the last dose of an experimental drug and receiving study drug.
- Patient Characteristics
- The patient must have adequate hepatic function \[alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) and bilirubin level ≤1.5 × ULN\].
- The patient must have adequate renal function (serum creatinine \< 1.5 × ULN).
- The patient must have the following hematological values: granulocytes ≥1500/μL, platelets ≥75 000/μL and hemoglobin \>8 g/dL.
- The patient must have prothrombin time and partial thromboplastin time within normal limits.
- Other
- • Women of childbearing potential and male patients must agree to use a highly effective contraceptive method.
Exclusion
- The patient has clinically significant distant metastases.
- The patient is eligible to have surgical resection or radiotherapy, chemo-radiotherapy or chemotherapy.
- The patient has a nasopharyngeal tumour.
- The patient has AIDS, hepatitis C or hepatitis B.
- The patient has clinically significant renal or hepatic disease.
- Tumors are prone to bleeding.
- The patient is pregnant or lactating.
- The patient requires 'blood thinning' medications and can not safely discontinue the medication.
- The patient is currently enrolled in another clinical trial.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00412776
Start Date
December 1 2005
End Date
April 1 2008
Last Update
December 23 2015
Active Locations (122)
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1
Hospital Italiano Regional del Sur
Bahía Blanca, Argentina
2
Hospital Municipal de Agudos Leonidas Lucero
Bahía Blanca, Argentina
3
Centro de Estudio y Tratamiento de las Enfermedades Neoplasicas (CETEN)
Buenos Aires, Argentina
4
Hospital de Clinicas "Jose de San Martin"
Buenos Aires, Argentina